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    Summary
    EudraCT Number:2019-003521-21
    Sponsor's Protocol Code Number:GLPG2737-CL-203
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-11
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003521-21
    A.3Full title of the trial
    An exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease
    Studio esplorativo, randomizzato, in doppio cieco, controllato con placebo, multicentrico volto a valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di GLPG2737 somministrato per via orale per 52 settimane nei soggetti con malattia policistica renale autosomica dominante
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney disease
    Studio esplorativo, randomizzato, in doppio cieco, controllato con placebo, multicentrico volto a valutare l’efficacia, la sicurezza, la tollerabilità e la farmacocinetica di GLPG2737 somministrato per via orale per 52 settimane nei soggetti con malattia policistica renale autosomica dominante
    A.3.2Name or abbreviated title of the trial where available
    A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney di
    Uno studio per valutare gli effetti di GLPG2737 in soggetti con autosomica malattia renale policisti
    A.4.1Sponsor's protocol code numberGLPG2737-CL-203
    A.5.4Other Identifiers
    Name:naNumber:na
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGALAPAGOS NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGalapagos NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalapagos NV
    B.5.2Functional name of contact pointClinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressGeneraal de Wittelaan L11 A3
    B.5.3.2Town/ cityMechelen
    B.5.3.3Post code2800
    B.5.3.4CountryBelgium
    B.5.4Telephone number003215342900
    B.5.5Fax number003215342901
    B.5.6E-mailrd@glpg.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGLPG2737
    D.3.2Product code [G1117337]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeG1117337
    D.3.9.3Other descriptive nameGLPG2737
    D.3.9.4EV Substance CodeSUB184534
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Autosomal dominant polycystic kidney disease
    Malattia renale policistica autosomica dominante
    E.1.1.1Medical condition in easily understood language
    Autosomal dominant polycystic kidney disease
    Malattia renale policistica autosomica dominante
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036046
    E.1.2Term Polycystic kidney, autosomal dominant
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To characterize the effect of GLPG2737 on growth in total kidney volume (TKV) compared to placebo.
    - To evaluate the safety and tolerability of oral doses of GLPG2737 compared to placebo.
    Caratterizzare l'effetto di GLPG2737 sulla crescita del volume renale totale (TKV) rispetto al placebo.
    - Valutare la sicurezza e la tollerabilità delle dosi orali di GLPG2737 rispetto al placebo.
    E.2.2Secondary objectives of the trial
    - To characterize the effect of GLPG2737 on renal function (estimated glomerular filtration rate; eGFR) compared to placebo.
    - To characterize the pharmacokinetics (PK) of oral doses of GLPG2737 and its major metabolite G1125498 (M4) using population PK analyses.
    - Caratterizzare l'effetto di GLPG2737 sulla funzione renale (stimatovelocità di filtrazione glomerulare; eGFR) rispetto al placebo.
    - Caratterizzare la farmacocinetica (PK) delle dosi orali di GLPG2737e il suo principale metabolita G1125498 (M4) usando analisi di popolazione PK.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female subject aged 18 to 50 years, inclusive.
    2. Documented diagnosis of typical ADPKD, using the Ravine criteria.
    3. Rapidly progressive disease, defined as presence of all of the following:
    -TKV >750 mL, as determined on imaging not older than 5 years before screening. If historical imaging is not available or older than 5 years, imaging can be performed during the screening period according to local clinical practice (i.e. echography, magnetic resonance imaging [MRI]).
    -Mayo ADPKD Classification Classes 1C to 1E.
    4. eGFR at screening between 30-90 mL/min/1.73 m2 for subjects aged 18 to 40 years (inclusive), and between 30-60 mL/min/1.73 m2 for subjects aged 40 to 50 years.
    5. Blood pressure = 150/90 mmHg. In case the subject is treated for hypertension, he/she should be on a stable treatment regimen of antihypertensive therapy for at least 8 weeks prior to the screening visit, and during the screening period.

    Reference is made to the protocol for a complete overview of the inclusion criteria.
    1. Materia maschile e femminile di età compresa tra 18 e 50 anni, compresi.
    2. Diagnosi documentata dell'ADPKD tipico, utilizzando i criteri Ravine.
    3. Malattia rapidamente progressiva, definita come presenza di tutti i seguenti:
    -TKV> 750 ml, come determinato sull'imaging non più vecchia di 5 anni prima dello screening. Se l'imaging storico non è disponibile o di età superiore a 5 anni, l'imaging può essere eseguito durante il periodo di screening secondo la pratica clinica locale (ovvero ecografia, risonanza magnetica [MRI]).
    -Mayo Classi di classificazione ADPKD da 1C a 1E.
    4. eGFR allo screening tra 30-90 ml / min / 1,73 m2 per soggetti di età compresa tra 18 e 40 anni (inclusi) e tra 30-60 ml / min / 1,73 m2 per soggetti di età compresa tra 40 e 50 anni.
    5. Pressione sanguigna = 150/90 mmHg. Nel caso in cui il soggetto sia trattato per ipertensione, dovrebbe essere sottoposto a un regime terapeutico stabile di terapia antiipertensiva per almeno 8 settimane prima della visita di screening e durante il periodo di screening.

    Si fa riferimento al protocollo per una panoramica completa dei criteri di inclusione.
    E.4Principal exclusion criteria
    1. Congenital absence of 1 kidney, or subject had a previous nephrectomy or has a transplanted kidney or a transplantation is planned in the foreseeable future.
    2. Administration of polycystic kidney disease-modifying agents (e.g. tolvaptan) or interventions (such as cyst aspiration or cyst fenestration) within 12 weeks prior to the screening visit and during the screening period. In case tolvaptan is not being administered, this should bebecause of e.g. non-availability, intolerance, or physician's clinical judgment.
    3. Any condition or circumstances that, in the opinion of the investigator, may make a subject unlikely or unable to complete the study or comply with study procedures and requirements (e.g. unable to undergo MRI. For example subject's weight exceeds weight capacity of the MRI, ferromagnetic metal prostheses, aneurysm clips, severe claustrophobia, etc.).

    Reference is made to the protocol for a complete overview of the exclusion criteria.
    1. L'assenza congenita di 1 rene o soggetto ha avuto una precedente nefrectomia o ha un rene trapiantato o un trapianto è pianificato nel prossimo futuro.
    2. Somministrazione di agenti che modificano la malattia del rene policistico (ad es. Tolvaptan) o interventi (come aspirazione della cisti o fenestrazione della cisti) entro 12 settimane prima della visita di screening e durante il periodo di screening.Nel caso in cui tolvaptan non venga somministrato, questo dovrebbe essere a causa di es non disponibilità, intolleranza o clinica del medico giudizio.
    3. Qualsiasi condizione o circostanza che, a giudizio dello sperimentatore, può rendere improbabile o incapace un soggetto di completare lo studio o di conformarsi alle procedure e ai requisiti dello studio (ad es. Incapace di sottoporsi alla risonanza magnetica. Ad esempio, il peso del soggetto supera la capacità di peso della risonanza magnetica , protesi metalliche ferromagnetiche, clip per aneurisma, claustrofobia grave, ecc.).

    Si fa riferimento al protocollo per una panoramica completa dei criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    - Mean percent change from baseline of height-adjusted TKV (htTKV).
    - Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious AEs (SAEs), and TEAEs leading to treatment discontinuation.
    - Variazione percentuale media rispetto al basale del TKV regolato in altezza (htTKV).
    - Frequenza e gravità degli eventi avversi emergenti dal trattamento (TEAE), eventi avversi gravi emergenti dal trattamento (SAE) e TEAE che portano all'interruzione del trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the trial as specified in the protocol.
    Vari punti temporali durante la prova, come specificato nel protocollo.
    E.5.2Secondary end point(s)
    - Mean change from baseline estimated GFR (eGFR).
    - Estimated exposure (area under the curve [AUC], maximum plasma concentration [Cmax]), based on population PK analyses of GLPG2737
    and its major metabolite M4
    - Variazione media dal GFR stimato al basale (eGFR).
    - Esposizione stimata (area sotto la curva [AUC], plasma massimo concentrazione [Cmax]), sulla base delle analisi di popolazione PK di GLPG2737 e il suo principale metabolita M4
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints throughout the trial as specified in the protocol.
    Vari punti temporali durante la prova, come specificato nel protocollo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study (EoS) is reached when the last follow-up visit, as planned according to the Schedule of Activities of the last subject is performed.
    La fine dello studio (EoS) viene raggiunta quando viene eseguita l'ultima visita di follow-up, come pianificato secondo il Programma delle attività dell'ultima materia.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    An open label extension study is planned and will be described in a separate protocol.
    È previsto uno studio di estensione in aperto e sarà descritto in un protocollo separato.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-03-01
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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